CSV Automation Engineer – Life Sciences (PLC/SCADA)

validationtechnologiesinc; California (MO); On-site; USD 80,000 - 105,000; Full time

Job summary

VTI Life Sciences in San Diego seeks a Computer System Validation (CSV) Specialist with Industrial Automation knowledge to validate computerized systems in regulated environments, including FDA cGxP, 21 CFR Part 11, and ISO 13485.

You will develop and execute validation protocols (IQ/OQ/PQ), support PLC/SCADA validation, and contribute to risk assessments, change control and documentation, while demonstrating strong technical writing and problem solving.

Qualifications

• Bachelor's degree or higher in Engineering, Life Sciences, or related field.
• 7+ years in FDA-regulated industry.
• Expertise in regulatory requirements and guidance, including 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.
• Familiarity with Python and Test Scripts.
• 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation.
• Must have experience working in an FDA-regulated environment.
• Experience with Automation Equipment such as HMI's, Robotized Manufacturing Systems and Vision Sensors. Experience in manufacturing and testing of Medical Devices.
• Advanced knowledge of PLC programming concepts and industrial automation architecture.
• Hands‑on experience with the Rockwell Automation suite and FactoryTalk View.
• Experience testing equipment alarms, error codes, interlocks, system messages, and abnormal operating conditions.
• Experience with databases, electronic records, part-traceability systems, and data-integrity principles.
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• Exceptional technical writing, review and analytical skills.
• Knowledge of good documentation practices and cGMP.

Responsibilities

• Authoring and Executing Software Testing,FAT, SAT, IQ, OQ, and Test Method Validation protocols.
• Draft, route, and execute Commissioning and Qualification Protocols (CQ, IQ, OQ, PQ) with Final Report.
• Scheduling and execution of qualification activities
• Qualification data collection and analysis against acceptance criteria.
• Drafting and/or reviewing User Requirement Specifications/Software Requirement Specifications.
• Software Design Specification drafting and review.
• Documentation generation and updates (SOPs, PFMEA, Forms, etc.)
• Meeting attendance and project coordination.
• Provide all services in accordance with FDA cGxP guidelines and regulations.

Skills

Python

SQL

Rockwell Automation

FactoryTalk View

FDA 21 CFR Part 11

Data Integrity

Automation Knowledge

Education

Bachelor's degree in Engineering or Life Sciences

Tools

HMI Systems

Vision Sensors

PLC Programming

Job description

VTI Life Sciences in San Diego seeks a Computer System Validation (CSV) Specialist with Industrial Automation knowledge to validate computerized systems in regulated environments, including FDA cGxP, 21 CFR Part 11, and ISO 13485.

You will develop and execute validation protocols (IQ/OQ/PQ), support PLC/SCADA validation, and contribute to risk assessments, change control and documentation, while demonstrating strong technical writing and problem solving.